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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01161433
Other study ID # 32583-E/B
Secondary ID HHSA290200600022
Status Completed
Phase N/A
First received June 15, 2010
Last updated July 9, 2010
Start date October 2007
Est. completion date September 2008

Study information

Verified date July 2010
Source University of Washington
Contact n/a
Is FDA regulated No
Health authority United States: Federal GovernmentUnited States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

Spirometry is a recommended component of asthma diagnosis and treatment in the primary care setting, however, few primary care providers report routine use of spirometry in the provision of care for their asthma patients. Even when spirometry is used to aid in asthma severity classification, primary care providers have a high rate of failing to meet the quality goals for testing established by the American Thoracic Society.

The goal of this study is to evaluate the effectiveness of a virtually delivered quality improvement (QI) program. The program is designed to train primary care providers and their medical staff in the use of spirometry to improve pediatric primary care management for children with asthma.


Description:

A cluster randomized trial with matched practice pairs. All practices receive a spirometer and standard vendor training. Those randomized to the intervention group receive a 7-month QI program, which includes:

1. Spirometry Fundamentals™ CD-ROM;

2. Case-based, interactive webinars; and

3. an Internet-based spirometry quality feedback reporting system.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- Internet access on a computer running Windows XP SP2

- Access to a computer with Windows 2000 /Mac OS 10 or higher

- Practices must match another enrolled practice on the following parameters.

1. Number of providers in practice (same number +/- 1 provider)

2. Location - both practices must either be urban or rural

3. % of patients eligible for Medicaid (same percentage +/- 15%)

4. Practice type (school-based clinic, Federally Qualified Health Center, private practice, hospital- or university-based clinic)

5. Geographic distance (minimum of 10 miles away from matched pair practice)

Exclusion Criteria:

- Lack of Internet access on a computer running Windows XP SP2

- Lack of access to a computer with Windows 2000 /Mac OS 10 or higher

- Practices that were unable to be matched to another similar practice

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Health Services Research


Related Conditions & MeSH terms


Intervention

Behavioral:
Virtually delivered spirometry quality improvement program
Sites in the intervention arm receive the virtually delivered QI program. The program includes: Spirometry Fundamentals™ CD-ROM, a computer-based CD-ROM training program that teaches primary care providers and their staff techniques required to perform high-quality spirometry tests, and proper interpretation of spirometric data; Case-based, interactive webinars; and an Internet-based spirometry quality feedback reporting system.

Locations

Country Name City State
United States University of Washington Seattle Washington

Sponsors (1)

Lead Sponsor Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Spirometry test quality Percentage of acceptable quality spirometry tests as determined by standards set by the American Thoracic Society. Seven months No
Secondary Presence of asthma care plan To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which written asthma action plans are completed. Seven months No
Secondary Asthma severity documentation To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which asthma severity is appropriately documented. Seven months No
Secondary Appropriate prescription of controller therapy To assess whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which appropriate controller therapy is prescribed. Seven months No
Secondary Frequency of office-based spirometry To test whether exposure to the virtually delivered quality improvement (QI) program increases the frequency with which office-based spirometry is used in the management of children with asthma. Seven months No
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